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Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)

NCT07587099 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2170

Last updated 2026-05-19

No results posted yet for this study

Summary

This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The study aims to assess rates of ischemic and bleeding adverse events.

Conditions

  • Coronary Heart Disease (CHD)

Interventions

DEVICE

Drug-coated balloon

Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.

DRUG

Single antiplatelet therapy (SAPT)

The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.

DRUG

Dual antiplatelet therapy (DAPT)

The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.

Sponsors & Collaborators

  • Gan Lijun

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587099 on ClinicalTrials.gov